Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol; Technical Amendment
other · Food and Drug Administration · Rule · Published 2003-09-23 · Effective 2003-09-23 · 68 FR 55199
Document
Document number
03-24161
Federal Register citation
68 FR 55199
CFR reference
21 CFR 522
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-09-23
Effective date
2003-09-23
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an additional dose of trenbolone acetate and estradiol implant for use in feedlot steers for increased rate of weight gain and improved feed efficiency. This section of the regulations is also being amended to remove a redundant description of another strength implant. This action is being taken to improve the accuracy of the regulations.